IonMAN II Trial- Early Feasibility Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System

This is a prospective, multi-center, single-arm, open-label, early feasibility study to provide preliminary evidence for the safety and efficacy of the novel IoNIR stent system

Inclusion Criteria: 1. Age ≥18 years. 2. Patient with an indication for PCI including NSTEMI (biomarkers have peaked or are falling), angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80, Pd/Pa≤0.91or iFR, RFR, DFR, DPR≤0.89 must be present). 3. Non-target vessel PCIs are allowed if performed \>30 days prior to index procedure. 4. Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. 5. Staged procedures are allowed as long as the IoNIR stent is implanted in the last procedure and at least 30 days have elapsed between the previous procedure and the IoNIR PCI. 6. A maximum of two vessels and up to two lesions may be treated (two lesions separated by up to 10mm that can be covered by a single stent are considered as one lesion). 7. Lesions requiring scoring/cutting and/or rotational/orbital atherectomy and/or intra-vascular lithotripsy are allowed. 8. Overlapping stents are allowed. 9. Target lesion must be in a major native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.0 mm and lesion length of up to 40 mm, and appropriate size IoNIR stents are available. Exclusion Criteria: * 1\. ST Segment Elevation MI within past 30 days. 2. NSTEMI with biomarkers that have not peaked. 3. Significant valvular disease or planned valvular intervention. 4. PCI within the 30 days preceding the baseline procedure. 5. PCI in the target vessel within 12 months of the baseline procedure. 6. Planned staged procedures (coronary or valvular), where the study stent is implanted in the first stage. 7\. Brachytherapy in conjunction with the baseline procedure. 8. Known history of stent thrombosis. 9. Cardiogenic shock (defined as persistent hypotension (systolic blood pressure \